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RotaScope Classic Cabinet

Manual Version

1.04

Date

23 November 2021

OPERATION/USE Verification

How to Verify Correct Installation and Operation of the Device:

5.1.1

Verification of correct installation

Follow the IQ and OQ procedure as per EN16442:2015 Standards

–

this should be

performed by the Authorised Distributor

5.1.2

Verification of correct maintenance

Manage the annual servicing requirements via an Annual Service Agreement

5.1.3

Verification of correct cleaning/disinfection.

Arrange the correct PQ (Performance Qualification) to be done in accordance with
EN16442 or local standard.

5.1.4

Operational environment

The cabinet should only be used indoors and in a controlled environment of 0

–

Degrees Celsius

5.1.5

Using the device in combination with other devices

The Cabinets are designed to only be used with Smartline approved devices
including the SmartStation (printer) and Communications kit PC. (See section in this
manual

–

SmartStation

2.12

and Communications Kit

2.12.3

)

5.1.6

Instructions for devices emitting hazardous radiation

Zebra LS2208 Laser Barcode Readers are used with the cabinet system

Laser safety: - Laser CDRH Class II; IEC Class 2, 5.0 V DC, 200 mA

5.1.7

Instruction for devices that are composed of substances or of combinations of
substances that are intended to be introduced into the human body

–

Not applicable

5.1.8

Manual operating techniques

A Hard Reset function may be carried out by the user should there be a need to do
so, typically instructed by an Authorised Distributor

•

Push the reset button located at the top of the cabinet behind the front
façade

•

The Data system and cabinet air system will restart after a Hard Reset

Содержание RotaScope Classic Series

Страница 1: ...RotaScope Classic Cabinet Manual Version 1 04 Date 23 November 2021 1 Installation and User Instructions RotaScope Classic Series Endoscope Drying Cabinet ...

Страница 2: ...for improvements or amendments or have found errors in this publication please notify us All pertinent state regional and local safety regulations must be observed when installing and using this product For reasons of safety and to help ensure compliance with documented system data Authorised Distributor technicians shall perform repairs to components When devices are used for applications with te...

Страница 3: ...information about company names products and services mentioned in this manual Trademarks shown below were derived from various sources All trademarks are the property of their respective owners General Notice Some product names used in this manual are used for identification purposes only and may be trademarks of their respective companies ...

Страница 4: ...t 14 2 5 Product Compliance 14 2 5 1Compliance Labels 14 2 6 Product elements 17 2 6 1RotaScope Cabinet Components 17 2 6 2IAS Components 18 2 6 3System Connection Overview 19 2 6 4Internal Cabinet Components 20 2 7 Understanding Product and Controls and Indicators 23 2 7 1What is the product 23 2 7 2How does the product work Overview 23 2 8 Understanding the User Interface 27 2 9 Operating Panels...

Страница 5: ...Safety information related to the intended use and reasonably foreseeable misuse 48 3 1 5 Personal Protective Equipment 49 3 1 6 Product limitations and restrictions 49 3 1 7 Maintenance safety information 50 3 2 General Anatomy of an Endoscope 50 3 3 Scope Connector Hose Kits 51 3 3 1 Scope Connector Hose Kits Colour Coding 52 3 3 2Scope Connector Hose Kits Cleaning IFU 53 3 3 3 Selecting Scope C...

Страница 6: ...80 4 2 9 Data and Power Schematic 81 4 2 10 Required Tools 82 4 3 How to Commission the Product 82 4 3 1 Installation of the software 82 4 3 2 Calibration of the device 82 5 OPERATION USE Verification 83 5 1 1 Verification of correct installation 83 5 1 2 Verification of correct maintenance 83 5 1 3 Verification of correct cleaning disinfection 83 5 1 4 Operational environment 83 5 1 5 Using the d...

Страница 7: ...8 1 How to Disassemble the Product 88 8 2 How to Recycle Parts 89 8 3 How to Dispose the Product 89 8 3 1 Test procedure to facilitate safe disposal of the device and related waste substances 89 8 3 2 Disposal of the device 90 8 3 3 Disposal of waste substances 90 8 3 4 Disposal of electronic components 90 8 3 5 Disposal of packaging waste 90 8 3 6 Disposal of batteries 91 9 APPENDIX I SUPPLIED AC...

Страница 8: ...pproved accessories and or performs the unloading loading of the Endoscopes in the RotaScope The User must not tamper or modify the RotaScope Any modifications servicing or repairs must be done by a Smartline Medical Trained Professional or a Trained Professional that is under instruction from Smartline Medical This document is intended for the User and Smartline Medical Trained Professionals of t...

Страница 9: ...ed Distributor Only Approved Distributors may install service or repair Smartline Medical equipment Avoid contact of electrical components with water and moisture Do not connect to any external electronic devices Do not lean on cabinet HEAVY Do not lift cabinet without lifting equipment Warning Integrated Air System Machine Noise 47 Decibels maximum measured at 1 Meter distance Only Approved Distr...

Страница 10: ...ct The manufacturer is not liable for cases of material damage or personal injury caused by incorrect handling or non compliance with the safety instructions In such cases the warranty will be voided 1 4 Obtaining Documentation and Information 1 4 1 Internet The latest version of the documentation is available at the following address http www smartlinemedical com 1 4 2 Ordering Documentation Wher...

Страница 11: ...the manufacturer The following natural or legal person makes the device to which this user manual applies suitable for use within the European Union and is considered to be the manufacturer of the device Smartline Medical 55 Cordwell Road Yandina Qld 4561 61 07 54789977 www smartlinemedical com au ...

Страница 12: ...Hose Connection Kits Purchased Separately ScopeManager software application It is essential that the user of this manual is aware of the potential hazards associated with the unit and its accessories All operators should be familiar with the safety precautions and warnings given in this section prior to attempting to operate the unit If the unit is used in a manner not specified by the manufacture...

Страница 13: ...elp reduce reprocessing costs and deliver operational efficiency and save time and costs Out of the Cabinet 2 3 Minimum System Requirements Computer and Processor 1 1 gigahertz GHz 64 bit dual core processor Operating System Windows 10 NOTE The Scope Manager Software is to be installed on a laptop or via a local a PC with Wi Fi The operating system is an integral part of the cabinets and SmartStat...

Страница 14: ...els RotaScope Cabinet Compliance Label affixed at top front of cabinet behind the façade Parameter Unit Device name RotaScope Classic Series Designation Class 1 Type Endoscope Storage Cabinet UNSPC Commodity Code 42295002 Customs HS Code 9018908400 Technical life span 7 Years Expiry Date N A Capacity Up to nine 9 endoscopes Energy consumption 250W Size Mass 2363mm H x 600mm W x 600mm D Base Cabine...

Страница 15: ... the IAS SmartStation Label is fitted to the side of the SmartStation see labels below 2 5 1 1 RotaScope Cabinet Product Compliance Label Located at the top front of the Cabinet behind the façade 2 5 1 2 Integrated Air System Compliance label Located on the right rear side of the IAS on top of the cabinet ...

Страница 16: ...RotaScope Classic Cabinet Manual Version 1 04 Date 23 November 2021 16 2 5 1 3 SmartStation Compliance Label Located on the side of the SmartStation mounting enclosure ...

Страница 17: ...r 2021 17 2 6 Product elements 2 6 1 RotaScope Cabinet Components The Cabinet may be configured with a Rear Door if it is the Pass Through version The Cabinet may also include an X Ray Kit on the rear door to prevent transmission of the X Ray through the cabinet ...

Страница 18: ...d devices The 4 POE ethernet ports located on the right side are for connecting Ethernet cables CAT 6 from the cabinet to other cabinets and for connecting SmartStation units A router device may also be connected to the unpowered ethernet socket to enable multiple cabinets to be connected The router also enables technicians to remotely login to the data system for service and support purposes NOTE...

Страница 19: ...an IAS Integrated Air System The connecting Ethernet cables may be linked directly as drawn or via Point to Point wall sockets as specific to your site design please confirm your site specific layout details when ordering The ROUTER connects multiple Cabinets The ROUTER enables remote access for service and support The ROUTER should be connected to the Port labelled Ethernet on the IAS at the top ...

Страница 20: ...on scopes and easy to clean Hang Hooks may be adjusted high or low for Long or Short Scopes and easy access The Centre Pole can be manually rotated for scope selection The Vacuum Manifold above left is the point that each scope is connected to the cabinet airflow via the Scope Hose Connection Kits described later in this document The Top Plate Top Disk retains the Hang Hooks and has vacuum airflow...

Страница 21: ...all to suit your scopes Various ENT Hooks are available and an Authorised Distributor will assist you with ordering special needs hang hooks will hold most types of flexible scopes A mix of ENT and Standard Hang Hooks may be used in a cabinet at the same time NOTE Where mixed hang hooks are located in one cabinet it will be necessary to assign the scope to a particular location Position Number whe...

Страница 22: ...and Manifold Details RotaScope Centre Pole OVERVIEW The Top Disk of the centre pole The hang hooks may be selected to suit various types and lengths of scopes Please see your Authorised Distributor for assistance in better understanding the various Hang Hook Options to make hanging scopes easy and safe ...

Страница 23: ...s of biofilm or free radical bugs from proliferating After reprocessing in simple terms A dry scope is a good scope For each stored scope there are 7 small luer hose connection nipples located on the manifold and Top Disk of the centre pole The manifold provides vacuum that draws air through the small hoses that run inside of the endoscope to dry each tiny channel tube Lumen Scope Connector Hose K...

Страница 24: ...s occur for various warning methods and record keeping Operation of the cabinet Short Description for Loading a Scope At AER Washer Scan the scope out of the AER via the SmartStation to validate that a scope was washed Scan Operator ID Barcode then scan Scope ID Barcode then scan Chamber ID Barcode located on the Washer Audio prompt LONG WASH or SHORT WASH Collect Printed Sticker from SmartStation...

Страница 25: ...out 1 5 hours from time of loading a scope The scope channels usually DRY in under 1 5 hours The slowest part of a scope to dry is the external control knobs on the scope control handpiece which can take up to three hours less if patted dry with clean lint free cloth before loading For best results Smartline recommends purging bulk moisture out of scopes before loading by use of medical air gun to...

Страница 26: ...t of sensors for each channel port of the manifold sensor board Some scope channels are Y junctions despite the joins each channel is seen independently as the air is drawn from each port so that there are no amalgamated air flows thus the cabinet can dry each channel or section of scope channel independently Cabinet environmental conditions Recommended that the cabinet is located in room with con...

Страница 27: ...igate to further Detail Screens by touching the section that you want further information about e g Control Panel Cabinet Control Screen The Cabinet Control Screen is located on the front cabinet door and rear cabinet door if fitted Uses of this Cabinet Control Screen Include View Cabinet Environmental Status E g Temperature Humidity View Scope Status Location Name Remaining Time Remaining OOC Dry...

Страница 28: ...opic each area acts as a button to the detail screen Press the relevant Icon see below Coloured icons indicate status E g RED colour indicates Over temperature CHECK CABINET Press to go to detail screen Scope status is indicated by Colour RED if there is a problem or if expired REPROCESS SCOPE Press to go to detail screen WHITE if the scope is fit for use Indicates No Scope Loaded RED if door is o...

Страница 29: ...g Location 1 Hook SCOPE NAME e g S1 SCOPE TYPE e g GASTROSCOPE SCOPE SERIAL NO e g 00000001005 WASH TIME e g 14 24 22 July 2021 Time and Date WASHED BY e g Ben Morris Who Unloaded AER Washer MAX STORAGE HRS e g 744 Storage Duration from AER unload STORED BY e g SARAH Jones Operator Name ID MAIN press to return to the Main Control Screen EXPIRE SCOPE FORCE REMOVAL Press to remove all scopes at one ...

Страница 30: ...ystem ON OFF LOCK CABINET Press to Lock the cabinet Use Operator ID Barcode Tag to scan to Unlock HELP Press for further help REMOVE ALL SCOPES FOR CLEANING Press to remove all scopes for weekly cabinet cleaning The user features are HELP Button that leads to the Help Display which features cheat sheets troubleshooting and instructional videos REMOVE ALL SCOPES FOR CLEANING Button which is a short...

Страница 31: ...dings from environmental sensors The MIN Minimum and MAX Maximum values where applicable are displayed to the right 2 10 Visual Signals at Cabinet Cabinet Environmental Lighting changes with status and errors are displayed on screen and errors are printed via the SmartStation Printer Cabinet coloured lighting indicates overall cabinet status as below ...

Страница 32: ...an AER i e Clean Door Control Screen Voice 3 Cabinet Cleaning Scan Operator ID Barcode Staff ID Badge Audio Tone Operator then press Cabinet Clean Button on Main Screen Audio Tone Cleaned Used when cleaning cabinet weekly Door Control Screen Voice 4 Loading a Scope Scan Operator ID Barcode Staff ID Badge Audio Tone Operator Scan Scope ID Barcode Audio Tone Scope Open Door Load Scope and Connect Sc...

Страница 33: ...Scope Status Various information is available by navigating through touch activated screens Cabinet Control Screen Screen Display Cabinet Clean Due Date Located on Cabinet Control Main Screen Clean Due Date advances by 7 days when Operator Staff ID Barcode is scanned followed by pressing Cabinet Clean Button Cabinet Clean Record prints at printer located on the SmartStation NOTE When a Cabinet Cle...

Страница 34: ...et Manual Version 1 04 Date 23 November 2021 34 2 11 3 Labels at SmartStation Print Station See labels below Wash Label Cabinet Clean Record Storage Label Power Outage Record Incorrect Scope Removal Environmental Alarm Labels ...

Страница 35: ...sed to deliver system warnings and various printed stickers for different reported functions The SmartStation is used to AER Load Unload AER Scan Operator Barcode Scope Barcode AER Chamber Barcode to load the scope into the AER Washer Reprocessing area Scan Scope Barcode and print scope status at any location to validate the status of the scope Used to print Error or Warning labels for reporting s...

Страница 36: ...ation Touchscreen Display The Touch Screen display shows the station and application details and may be set up differently depending on the configuration of your site This intuitive device with Touch Screen may be used in conjunction with the Barcode Scanner to scan Operator ID Scope ID and various function Barcodes ...

Страница 37: ...urred in alignment with Scope manufacturer and AER manufacturer instructions for use IFU and in an Approved Endoscope Reprocessing Cycle as per the hospital guidelines in your region AER Chamber Barcode Labels are used to identify each AER Washer and each Washer Chamber as a unique identifier The AER Chamber Barcode Labels are set up at installation by the Authorised Distributor AER Chamber Barcod...

Страница 38: ...are available from an Authorised Distributor Typically the SCOPE ID BARCODE STICKER is located on the Endoscope Handpiece as indicated in this diagram The Barcode should be easily visible so that scanning process can occur The Barcode Sticker has no effect on the use or decontamination of the scope The barcode may be easily removed if the scope is decommissioned Image above shows the supplied Scop...

Страница 39: ...select to scan either LONG STORAGE or SHORT STORAGE Time Barcode when Unloading the AER NOTE If Long Storage is required most usual then this step may be omitted i e Use only steps 1 2 4 see notes about Long Storage and Short Storage under Barcodes Long Storage in the Definitions Section of this manual Scanning toggles the long short function Short and Long Barcode Labels are located on the SmartS...

Страница 40: ...g OUT When scanning a scope OUT of a washer a digital record identifies who unloaded the scope from the AER and which AER chamber the scope was washed in along with time date and operator details when unloading A Scope Wash Record Sticker is printed IMPORTANT Operators must make a Critical Decision upon UNLOADING The Operator must 1 Confirm that the selected AER cycle was completed successfully By...

Страница 41: ...ive Operator Tag s Wi Fi Dongle Extra Washer Plaque Barcodes In Out Extra Staff ID Barcodes Extra Scope ID Barcodes The Laptop has the Scope Manager Software installed If a Communications Kit is purchased the Laptop Computer will be set up at installation the laptop has Wi Fi connectivity to the Cabinets and SmartStations The laptop can be used to Set up Staff ID Barcodes Set up Scope ID Barcodes ...

Страница 42: ...e is installed by an Authorised Distributor upon set up of the site however from time to time the software my need to be reinstalled due to PC replacement or reconfiguration or as below 1 Using the USB provided in the Communications Kit or from the Authorised Distributor run the Scope_Manager_2_1 Install Application 2 Right Click and Run as Administrator 3 Install the Application and create a shor...

Страница 43: ... Scope ID Barcode Tag supplied with Laptop Kit a Note If scopes already have a 10 digit barcode attached this barcode can be used in place of adding a new Smartline barcode 4 Type in the 4 digit Barcode Number into the Scope ID Box preceded by 000000 as shown above 5 Select the Type of Scope from the Drop Down menu E g GASTROSCOPE 6 If required adjust the OOC and Max Storage time in HOURS 7 Press ...

Страница 44: ...ES and Scope Location The simple layout of the screen allows you to select the function Make sure the laptop is connected to the wifi network of the cabinet The MASTER CABINET IP Address is Printed on the ROUTER above or near the Scope Cabinets Click on Function Tab OPERATOR Find a spare USER ID BARCODE Operator Tag supplied with Laptop Kit Type in the Operator Tag Barcode Number into the OPERATOR...

Страница 45: ...the power cable securely plugged in power turned On Inspect all data system components power cables are securely plugged in power is switched On Inspect all data system components accessories connection cables for functionality wear tear or damage Inspect the digital display for normal function If any inspection fails please advise your supervisor as soon as possible The Cabinet Environmental Moni...

Страница 46: ...l Occupational Health Officer to determine a safe work method for your site 3 1 1 Control screens and electrical enclosures Do not open and access the control units without specific training from the Authorised Distributor 3 1 2 Technical life span Annual service and preventative maintenance are required o To ensure you get the best performance out of your Cabinets it is an operational requirement...

Страница 47: ...hat are in use in the HSO Refer to clause 5 2 and e When introducing new or modified RMD packaging or loading configurations unless equivalence to a previously qualified reference load RMD product family packaging or loading pattern has been demonstrated Requalification of the process shall be performed annually Refer Clause 10 4 Smartline Medical does offer a performance Qualification Service for...

Страница 48: ...annels blown dry with medical air from handpiece ports including biopsy channel and thumb ports for suction and air water Verification is required that all channels allow the passage of air before the device is loaded into the storage cabinet Endoscopes should be transferred into storage drying cabinet as soon as possible after endoscope has completed all of it set cleaning phases Take care to not...

Страница 49: ...les of AER Automatic Endoscope Repressors should be set to allow for the removal of bulk liquids where possible and or Endoscopes should be purged by manual purging to remove bulk liquid before loading into the drying cabinet Endoscopes that have undergone manual cleaning processes only should be purged of bulk liquids before loading into the drying cabinets Note 2 Strong recommendation is given t...

Страница 50: ... covering servicing and or replacement of equipment e g filters and parts Maintenance is to be conducted by Authorised Distributors only 3 2 General Anatomy of an Endoscope The image above outlines the various parts of a typical thermolabile flexible endoscope Whilst the design and functions of endoscopes may vary the Drying Principles remain the same across various scope families and brands The c...

Страница 51: ...or each approved scope Each hose is colour coded and matched with the correct port fittings so that the scope channels can be connected to the scope and system correctly A colour coded sticker on the scope cabinet Vacuum Manifold Blocks is used to visually match the coloured hose with the coloured sticker Colour Coded Scope Connector Hose Kit Examples Pole Manifold Hose colour is matched to simila...

Страница 52: ... OD mm Colour Sample Handpiece Auxiliary 1 4 0 6 5 BLACK Biopsy 2 4 0 6 5 WHITE Spare 3 4 0 6 5 LT GREY Umbilical Suction 4 5 8 9 0 DK GREY Air 5 4 0 6 5 LT GREEN Water 6 4 0 6 5 LT BLUE Auxiliary Jet 7 4 0 6 5 BLACK Lower Air Pipe 3 2 6 4 CLEAR NOTE See your Authorised Distributor for detailed selection of Scope Connector Hose Kits to suit your specific Endoscope connection to the cabinet air sys...

Страница 53: ...ectors at each end of the hose 5 Wipe exterior surfaces of hoses with a nonabrasive and lint free cloth 6 Check that all visible debris have been removed 7 Optionally attach hoses to a Washer Rack Hose Connection Kit 8 Use a syringe to push fresh solution through hoses and then flush out Repeat a minimum of two more times do not flush out on last action 9 Achieve contact time with hoses submerged ...

Страница 54: ...doscope Model Number it is very important to exactly capture the precise details including Capital and lower case letters hyphens numbers and spacings e g EC 760ZP V L Examples of approved scope kits can be seen below As there are so many they are not listed individually in this manual please refer to the ApprovedScopeList pdf and refer to your local Distributor to obtain full details of each requ...

Страница 55: ... Washer the 4 Luer connections are connected to cabinet Scope Connector Hose Kits Note Scope Connector Hose Kits join Endoscopes to the RotaScope Drying Cabinet airflow system High level disinfection of each Scope Connector Hose Kit should be undertaken weekly during the Cabinet Cleaning Cycle Cleaning may be Manual or Automated and can also be autoclaved to gain shelf life During Weekly Cleaning ...

Страница 56: ...binet interior exterior surfaces to be cleaned using soft clean cloths non abrasive cleaning disinfecting products that do not contain ammonia or alcohol Any abrasive cleaning product or cloth scourers will permanently mark the surface and should be avoided Do not allow electrical or electronic components to become wet or splashed with water or other fluids Any fluids issuing from recently loaded ...

Страница 57: ...cabinet The recommended cleaning technique is to wipe all interior surfaces with a non alcoholic disinfectant wipe Cleaning the human touch points where operators frequently touch is particularly important Methodical manual cleaning of these points should occur Hang Hooks should be frequently cleaned Any fluids inadvertently spilled or dripped onto the cabinet are to be wiped up immediately using ...

Страница 58: ...res for cleaning an operating room If the cabinet is located in a scope processing room follow typical procedures for cleaning a scope processing room NOTE Please do not use cleaners containing ammonia or alcohol or abrasive materials as it may damage cabinet surfaces NOTE Detergent Wipes and or Disinfectant wipes may be used to clean the external surfaces of RotaScope cabinets This page may be pr...

Страница 59: ...nets are manufactured using mostly acrylic plastics stainless steel and ROHS approved electronic components Most parts can be substantially recycled for care of the environment However the cabinets should be thoroughly cleaned before disposal and consultation with local recycling parties should be undertaken in accordance with your environmental infection control and recycling policy ...

Страница 60: ... Authorised Distributor The service will include inspection calibration if required and includes the replacement of filters pumps and is described in detail in the Annual Service Agreement Approved Scopes See list of Approved endoscopes appendix listing scopes approved as suitable to be dried and stored in RotaScope Cabinets See ApprovedScopeList pdf Barcode AER Chamber SmartStation Barcode Sticke...

Страница 61: ...n the Scope ID is setup the first time To select the SHORT STORAGE Time using the Barcode Scanner swipe SHORT STORAGE Time Barcode Sticker Operator ID Barcode Scope ID Barcode AER Chamber Barcode Sticker 4 Scans Barcode Short Storage or Long Storage The LONG STORAGE Barcode Sticker is located at the SmartStation by the AER Washer The LONG STORAGE Barcode is scanned as part of loading the scope int...

Страница 62: ...e other screens display details about cabinet pressure pump temperature and speeds and cabinet humidity and temperature The main screen is usually all an operator needs to see including scope details and current status eg drying or dry Clear simple icons denote scope drying status and remaining storage time Selecting a scope with the least remining time allows efficiency in reducing scope reproces...

Страница 63: ...or locks are located in the middle of each door behind the door handle the locks are controlled by swiping a staff barcode below the Cabinet Control Screen to unlock If configured as a Pass Through cabinet with a rear door fitted the door locks are configured as Interlocking allowing only one door to be opened at a time In case of a power failure the door can be unlocked by inserting a 9V Battery ...

Страница 64: ...int 110 240V Hard Reset A Hard Reset may be done by using the Hard Reset Button which is located at the top of the cabinet behind the top façade The hard reset button restarts the Linux Computer System and normal operating parameters The cabinet will reset and restart after pressing the Hard Reset Button this Hard reset is usually performed when prompted by a support technician in case of a defaul...

Страница 65: ...s that connect scope channels via Colour Coded Connection Hoses to the Vacuum air flow for drying the scope channels Lumens Match hose colour to the coloured stickers to ensure correct connection OOC Out of Cabinet Time Displayed on Main Cabinet Control Screen OOC is the recorded countdown time that a scope is not in the cabinet OOC is a total of 3 hours 180 Minutes OOC starts upon swiping the bar...

Страница 66: ...nd accessories to enable the sustained storage of thermolabile endoscopes to meet Standard EN16442 2015 Router A data router connects multiple cabinets together and may connect to the Printer Station and Washer Station for collecting data from the process of washing a scope through the AER Washer or from a scope scanned at the printer The router may also play a role in notifications of errors by s...

Страница 67: ...ion of a Display screen and Linux Controller used with a Barcode scanner to Scan the Operator and Scope into and out of an AER Washer X Ray Door Kit An X ray proof optional door kit may be fitted to Pass Through Cabinets to assist in the prevention of X Rays being transmitted through the cabinet ...

Страница 68: ...raphical symbols in relation to the product Symbol Meaning Warning Caution IEC Mains Power Supply CE Certification Date Of Manufacture FCC Compliance Instructions For Use Icon Indoor Use Medical Device RCM Compliance Batch Number Recorded ROHS Compliance Serial Number Recorded Unique Device Identifier IEC DC Powered ...

Страница 69: ...d potential contamination of endoscopes and internal surfaces it is recommended scrubs are worn while interacting with the inside of a cabinet Gown In the instance that scrubs are not in use to avoid potential contamination of endoscopes and internal surfaces it is recommended gowns are worn while interacting with the inside of a cabinet Mask To avoid potential contamination of endoscopes and inte...

Страница 70: ...avy lifting equipment must be used Non commissioned cabinets should be stored in the corresponding crates or plastic film in a clean and dry area Do not attempt to lift cabinets without prior education and advice from a suitably trained technician The cabinet is delivered in a crate 800x800x2500mm which weighs approximately 160kg The crate should only be moved with mechanical lifting aids or a for...

Страница 71: ...cluding Lid Top Cap Cabinet including Control screen on Front Door 600mm Wide x 680mm Deep x 2363mm High Pass Through Cabinet including Control Screen Front and Rear Door 600mm Wide x 760mm Deep x 2363mm High Approximate Weight RotaScope 160Kg 107kg per m3 Fig 3 Cabinet Body Dimensions note add depth of Screen or Screens Front to Rear for Single or Pass Through doors ...

Страница 72: ... two persons minimum Storing the product RotaScope cabinets should be installed and stored in continuous operating environment ie Standard office working conditions need to be always provided Room temperature range 10 C to 30 C relative humidity between 40 and 70 To store the product safely Keep cabinet in crate until being transferred into desired installed position If the cabinet needs to be rem...

Страница 73: ... tag regime on power leads 4 1 5 Securing the product against electrical shock Keep the cabinet free from liquids Maintain a suitable install environment Indoor use only 4 1 6 Securing the product against impact Keep the cabinet protected against hard bumps by people trolleys and moving objects Maintain a suitable install environment Do not lean heavy objects against the cabinet ...

Страница 74: ...in if possible 5 Remove the packing straps from around the cabinet and pallet base dispose of in a General Waste Bin 6 Remove the cartons located at one end of the cabinet The Cartons contain Baskets and ancillary devices in cartons retain for use later 7 Remove the foam packaging edges from the cabinet and dispose of in a General Waste Bin 8 With two people carefully slide the cabinet base past t...

Страница 75: ...r screen is exactly the same as the front door screen The rear door allows scopes to be loaded in the Reprocessing Room but unloaded in the Procedure Room Operating Theatre Power and data points should have been installed during building construction of the wall so that cables neatly pass from the top of the cabinet to the power and datapoints Consult appropriate wall cut out drawings in the Smart...

Страница 76: ...RotaScope Classic Cabinet Manual Version 1 04 Date 23 November 2021 76 Cabinet Front located in the Reprocessing Room Cabinet Rear seen in the Procedure Room ...

Страница 77: ...roof Door shown 4 2 4 Power Connection 1 Depending on the site layout and location of cabinets plug in any SmartStations and cabinets by using ethernet cables and refer to the site layout drawing provided prior to install 2 Plug Cabinet power cord into a GPO 3 Plug SmartStation power cord into a GPO 4 Check the Cabinet ON OFF switch located on the side of the IAS at the top of the cabinet 5 Cabine...

Страница 78: ...e Ends 4 2 6 Verification of the product At completion of install a cabinet must be verified via the Authorised Distributor using the Smartline Medical approved Auditing Tools for an Installation and Operational Qualification IQ OQ in accordance with EN16442 and AS4187 or local standard Following this a Performance Qualification PQ should be carried out by a suitably trained technician and is the ...

Страница 79: ...space needed The cabinet has a total size of 600mm Wide x 600mm Deep x 2363mm High and requires a minimum of 1200mm Deep and 2400mm Ceiling height and must not be installed less than 100mm from any wall See diagram below Passthrough models require 1800mm deep Fig 4 Spatial Requirements ...

Страница 80: ...4 Date 23 November 2021 80 4 2 8 Layout plan Each Install Location requires a layout plan and schematic to be drawn prior to install A site layout and install document will be provided prior to installation for each site Fig 5 Example Layout Plan ...

Страница 81: ...taScope Classic Cabinet Manual Version 1 04 Date 23 November 2021 81 4 2 9 Data and Power Schematic Each install Requires a Data and Power Schematic prior to install Fig 6 Example Data and Power Schematic ...

Страница 82: ...ical level clean should be performed by the Hospital Departmental Staff In service training will be carried out by an appropriate training provider and is supplemented by video training 4 3 1 Installation of the software All cabinets are provided with pre installed software See also Communication Kit If supplied the laptop computer is loaded with the Scope Manager Software and is used for basic se...

Страница 83: ...ng the device in combination with other devices The Cabinets are designed to only be used with Smartline approved devices including the SmartStation printer and Communications kit PC See section in this manual SmartStation 2 12 and Communications Kit 2 12 3 5 1 6 Instructions for devices emitting hazardous radiation Zebra LS2208 Laser Barcode Readers are used with the cabinet system Laser safety L...

Страница 84: ... side of the IAS Integrated Air System which incorporates the electronic control devices of the Cabinet Control System The IAS is located on the top of the cabinet behind the removable façade 5 2 How to Use the Product Remotely Automatically Advanced operations shall only be done by an Authorised Distributor For remote service and access to advanced cabinet settings please contact your local Autho...

Страница 85: ...kly inspection tasks Task Frequency Replacing the Intake Filter Every 12 months Replacing HEPA Filter Every 12 months Replacing the Air Pumps Every 24 months Task Action Weekly Cabinet Clean Use Hospital Grade Disinfectant to wipe over every internal surface of the cabinet as per the IFU in this manual Weekly Scope Hose Connection Set Clean Clean Hoses or swap out with a previously cleaned hose ki...

Страница 86: ...uct does not start Power Failure Blown Fuse Electronic Failure Restore Power and reset via Alarm Acknowledge Button on Cabinet Control Screen Or replace a part via a service technician Cabinet WHITE Lights Stays On Door Open Close Door Cabinet lights colour is not GREEN Refer to cabinet lighting guide Green Normal Operation White Door Open Purple Power failure Orange Warning Red Failure Blue Clean...

Страница 87: ...my cabinet purple There has been a power outage you need to acknowledge this alarm via the control panel on the door touchscreen Following this be sure to check if the stored endoscopes are within their allocated storage timeframe 7 3 Repair 7 3 1 Repair by skilled persons All repairs must be done by an Authorised Distributor ...

Страница 88: ...parate Acrylic lid and housing from electrical parts group Acrylic with other Acrylic parts group electrical parts dispose of insulation stickers filter and silicone hoses f Remove Stainless parts and group with metal parts g Remove Acrylic Centre Disks Group disks with other Acrylic parts remove manifolds and separate electronic boards with electronic parts remove manifold body parts and group wi...

Страница 89: ... gather electronic control boards motors cables and fittings assess with a representative 3 Dispatch goods to a recycle company as agreed upon inspection 8 3 How to Dispose the Product 8 3 1 Test procedure to facilitate safe disposal of the device and related waste substances Devices are designed and manufactured to facilitate safe disposal and the safe disposal of related waste substances by the ...

Страница 90: ...EU and in other European countries that operate separate collection systems for waste electrical and electronic equipment By disposing of the device in the proper manner you help to avoid possible hazards for the environment and public health that could otherwise be caused by improper treatment of waste equipment The recycling of materials contributes to the conservation of natural resources There...

Страница 91: ...8 3 6 Disposal of batteries The product contains a CR2032 battery in the IAS Batteries may not be disposed of with the usual domestic waste They may contain toxic heavy metals and are subject to hazard our waste regulations For this reason dispose of used batteries at a local collection point To dispose batteries 1 Gather batteries 2 Identify type and recycling method 3 Dispose of batteries at loc...

Страница 92: ...ose Connection Kits Various Communication Kit COMMUNICATION KIT Labels N A 9 2 Consumables Image Name Part Number Tip Protector TIP PROTECTORS Channel Separators See Authorised Distributor 9 3 Spare replacement parts Image Name Part Number FUSE 6 3A Fuse holder at IEC Power Cable Socket Contact Smartline HEPA Filter in IAS HEPA FILTER H13 Intake Air Filter in IAS 47 AN302 ...

Страница 93: ...ol Board in IAS MOTOR CNTRL BOARD 24VDC Raspberry Pi in IAS Door Blister 48 2525226 IO Power Board in IAS IAS CABINET INTERFACE BOARD 24v Transformer in IAS TRANSFORMER MCC 24V 12v Power Supply in IAS 48 MP3490 Vacuum Sensor in IAS 48 SC CE PVM Cabinet pressure monitor in IAS 48 SC SY HTS Data Switch power pack in IAS 48 DGS 1008A ...

Страница 94: ...on 1 04 Date 23 November 2021 94 Door Lock Latch in door frame LOCK SOLENOID Door Cabinet Control Blister Assembly On cabinet door BLACK SILVER DOOR BLISTER IQ BLACK DOOR BLISTER SVR Power Board 48 SC CE PCB CR2032 Battery Contact Smartline ...

Страница 95: ...r sole responsibility that the device Basic UDI DI 9356523xxxx Device name Trade name RotaScope Cabinet Product code ROTA Catalogue number N A Intended purpose A dedicated range of cabinets designed to dry and store flexible endoscopes in a clean storage environment that prevents bacterial growth after processing Scopes are dried internally and externally by independently supplied clean HEPA filte...

Страница 96: ...RotaScope Classic Cabinet Manual Version 1 04 Date 23 November 2021 96 CE Declaration of Conformity 2021 P1 ...

Страница 97: ...RotaScope Classic Cabinet Manual Version 1 04 Date 23 November 2021 97 CE Declaration of Conformity 2021 P2 ...

Страница 98: ...cal com DW 2 CE Declaration Of Conformity F 218 V1 V1 sales smartlinemedical com Attached WS 3 Workflow Overview 2021 sales smartlinemedical com Attached DM 4 Barcode Setup Overview 2021 sales smartlinemedical com Attached DM NOTE This Manual will be frequently updated with additional information FAQ questions and more please refer to your Authorised Distributor for updated versions ...

Страница 99: ...RotaScope Classic Cabinet Manual Version 1 04 Date 23 November 2021 99 Workflow Overview ...

Страница 100: ...RotaScope Classic Cabinet Manual Version 1 04 Date 23 November 2021 100 Barcode Setup Overview ...

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